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Windtree Therapeutics Reports First Quarter 2025 Financial Results and Provides Key Business Updates

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Windtree Therapeutics (WINT) reported Q1 2025 financial results and strategic updates. The company posted an operating loss of $4.1 million, compared to $4.4 million in Q1 2024. Key highlights include:

The company is pursuing a new strategy to become revenue-generating through: - Acquiring FDA-approved assets - A right to purchase a 436-unit residential property in Houston - Partnership for PHEXXI® manufacturing cost reduction - China partnership expected to generate revenues by end of 2026

Financial position shows cash and cash equivalents of $1.2 million with current liabilities of $6.5 million. The company raised $2.6 million through Series D convertible preferred stock in April-May 2025. Notably, Windtree regained Nasdaq compliance but remains under monitoring until March 2026.

[ "Operating loss decreased from $4.4M in Q1 2024 to $4.1M in Q1 2025", "Secured $2.6M through private placement of Series D convertible preferred stock", "Regained Nasdaq compliance for minimum bid price requirement", "Expanded patent estate for istaroxime with new US allowance and India filing", "Secured rights to purchase revenue-generating 436-unit residential property" ]
Windtree Therapeutics (WINT) ha comunicato i risultati finanziari del primo trimestre 2025 e aggiornamenti strategici. L'azienda ha registrato una perdita operativa di 4,1 milioni di dollari, in miglioramento rispetto ai 4,4 milioni del primo trimestre 2024. Tra i punti salienti:

la società sta adottando una nuova strategia per generare ricavi tramite: acquisizione di asset approvati dalla FDA, diritto di acquisto di una proprietà residenziale di 436 unità a Houston, partnership per la riduzione dei costi di produzione di PHEXXI®, e una collaborazione in Cina che dovrebbe portare ricavi entro fine 2026.

La posizione finanziaria mostra 1,2 milioni di dollari in liquidità e mezzi equivalenti e passività correnti per 6,5 milioni di dollari. Tra aprile e maggio 2025 la società ha raccolto 2,6 milioni di dollari tramite azioni privilegiate convertibili di Serie D. Importante notare che Windtree ha riconquistato la conformità ai requisiti Nasdaq, sebbene rimanga sotto monitoraggio fino a marzo 2026.

Windtree Therapeutics (WINT) informó los resultados financieros del primer trimestre de 2025 y actualizaciones estratégicas. La empresa registró una pérdida operativa de 4.1 millones de dólares, mejorando respecto a los 4.4 millones del primer trimestre de 2024. Entre los puntos clave:

la compañía está siguiendo una nueva estrategia para generar ingresos mediante: adquisición de activos aprobados por la FDA, derecho a comprar una propiedad residencial de 436 unidades en Houston, asociación para reducir costos de fabricación de PHEXXI®, y una colaboración en China que se espera genere ingresos a finales de 2026.

La posición financiera muestra 1.2 millones de dólares en efectivo y equivalentes y pasivos corrientes por 6.5 millones de dólares. Entre abril y mayo de 2025, la empresa recaudó 2.6 millones de dólares mediante acciones preferentes convertibles Serie D. Cabe destacar que Windtree recuperó el cumplimiento de Nasdaq, aunque permanece bajo supervisión hasta marzo de 2026.

Windtree Therapeutics(WINT)는 2025년 1분기 재무실적 및 전략 업데이트를 발표했습니다. 회사는 410만 달러의 영업 손실을 기록했으며, 이는 2024년 1분기 440만 달러보다 개선된 수치입니다. 주요 내용은 다음과 같습니다:

회사는 수익 창출을 위한 새로운 전략으로 FDA 승인 자산 인수, 휴스턴 소재 436세대 주거용 부동산 구매 권리 확보, PHEXXI® 제조 비용 절감을 위한 파트너십, 2026년 말까지 수익 창출이 예상되는 중국 파트너십을 추진하고 있습니다.

재무 상태는 120만 달러의 현금 및 현금성 자산650만 달러의 유동 부채를 보유하고 있습니다. 2025년 4월~5월에 시리즈 D 전환 우선주를 통해 260만 달러를 조달했으며, Windtree는 나스닥 최소 입찰 가격 요건을 다시 충족했으나 2026년 3월까지 모니터링 상태를 유지합니다.

Windtree Therapeutics (WINT) a publié ses résultats financiers du premier trimestre 2025 ainsi que des mises à jour stratégiques. La société a affiché une perte d'exploitation de 4,1 millions de dollars, contre 4,4 millions au premier trimestre 2024. Les points clés incluent :

la poursuite d'une nouvelle stratégie visant à générer des revenus via : l'acquisition d'actifs approuvés par la FDA, un droit d'achat d'une propriété résidentielle de 436 unités à Houston, un partenariat pour réduire les coûts de fabrication de PHEXXI®, et un partenariat en Chine qui devrait générer des revenus d'ici fin 2026.

La situation financière montre 1,2 million de dollars en liquidités et équivalents avec 6,5 millions de dollars de passifs courants. La société a levé 2,6 millions de dollars via des actions privilégiées convertibles de série D entre avril et mai 2025. Notons que Windtree a retrouvé la conformité Nasdaq, mais reste sous surveillance jusqu'en mars 2026.

Windtree Therapeutics (WINT) berichtete über die Finanzergebnisse des ersten Quartals 2025 und strategische Updates. Das Unternehmen verzeichnete einen operativen Verlust von 4,1 Millionen US-Dollar, verglichen mit 4,4 Millionen im ersten Quartal 2024. Wichtige Highlights sind:

Das Unternehmen verfolgt eine neue Strategie zur Umsatzgenerierung durch: Erwerb von FDA-zugelassenen Vermögenswerten, das Recht zum Kauf einer 436-Einheiten-Wohnimmobilie in Houston, eine Partnerschaft zur Kostensenkung bei der Herstellung von PHEXXI® sowie eine Partnerschaft in China, die bis Ende 2026 Umsätze generieren soll.

Die Finanzlage zeigt Barmittel und Zahlungsmitteläquivalente in Höhe von 1,2 Millionen US-Dollar sowie kurzfristige Verbindlichkeiten von 6,5 Millionen US-Dollar. Im April-Mai 2025 hat das Unternehmen 2,6 Millionen US-Dollar durch eine Privatplatzierung von wandelbaren Vorzugsaktien der Serie D aufgenommen. Bemerkenswert ist, dass Windtree die Nasdaq-Compliance wiedererlangt hat, aber bis März 2026 weiterhin unter Beobachtung steht.

Positive
  • None.
Negative
  • Limited cash position of $1.2M against current liabilities of $6.5M
  • Only sufficient resources to fund operations through May 2025
  • Remains under mandatory Nasdaq panel monitor until March 2026
  • Revenue generation from China partnership not expected until end of 2026

Insights

Windtree's pivot to revenue generation through real estate and partnerships masks concerning financials with just weeks of cash runway remaining.

Windtree's Q1 2025 results reveal a company in a precarious financial position attempting a significant strategic pivot. The company reported an operating loss of $4.1 million, slightly improved from $4.4 million in Q1 2024, but their cash position of just $1.2 million against $6.5 million in current liabilities is deeply concerning. Management explicitly states they only have sufficient funds to operate through May 2025 – essentially just weeks of runway.

This explains Windtree's unusual strategic shift from being a pure-play biotech to seeking immediate revenue generation through unconventional means. The company has entered into a right-to-buy agreement for a 436-unit residential property in Houston and formed a manufacturing partnership for Evofem's PHEXXI contraceptive. These non-traditional pivots for a biotech company reflect desperate attempts to generate cash flow while continuing development of their lead asset istaroxime for cardiogenic shock.

While the company did manage to raise $2.6 million through a private placement in April-May 2025, this amount appears insufficient to meaningfully extend their runway. The recent regaining of Nasdaq compliance is overshadowed by the substantial dilution reflected in their share count increase from 9,295 to 1,088,564 weighted-average shares outstanding year-over-year.

The continued development of istaroxime with an interim analysis planned for Q3 2025 provides some scientific promise, but the company's unorthodox diversification into real estate and contract manufacturing signals serious financial distress. A 65% reduction in production costs for a Chinese biopharmaceutical partner won't generate revenues until late 2026 – far beyond their current cash runway, making additional financing or partnerships imperative for survival.

WARRINGTON, Pa., May 16, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the first quarter ended March 31, 2025 and provided key business updates.

“The first quarter of 2025 was marked with significant progress. We announced our new corporate strategy to become a revenue generating company by seeking to identify and acquire revenue-generating FDA-approved assets while advancing our cardiology and oncology pipeline,” said Jed Latkin, Chief Executive Officer of Windtree. Mr. Latkin continued, “We believe that this strategy has the potential to transform Windtree into both a commercial and development stage company that generates revenue, helps patients and enhances our attractiveness to shareholders. The Company entered into an initial strategic transaction for a right to buy a revenue-generating multifamily residential property. Leveraging off our firm partnership in China we are helping a rapidly growing biopharmaceutical company lower their costs of production by almost 65%. We anticipate the partnership should start generating revenues by the end of 2026. We continue to develop our pipeline, including the ongoing enrollment of subjects in the istaroxime cardiogenic shock SCAI Stage C study. We plan an interim analysis of the first 20 subjects in Q3 2025. This study, when completed, is intended to advance the program to Phase 3 in cardiogenic shock, a condition with significant mortality and morbidity. Drug innovation in cardiogenic shock is desired, and we believe that istaroxime has the potential to provide unique benefits over other currently available drugs. We look forward to continued communication with our shareholders on our progress on all our initiatives.”

Key Business Updates

  • Announced a late-breaking clinical science abstract presentation on istaroxime at the Technology and Heart Failure Therapeutics Conference.
  • Entered into a license and supply agreement to become the sourcing partner for Evofem Biosciences, Inc. for PHEXXI® (lactic acid, citric acid and potassium bitartrate), a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. The Company intends to leverage its manufacturing contacts to reduce pharmaceutical product cost of goods for PHEXXI.
  • Announced a strategic transaction to drive revenue generation in support of our ongoing therapeutic pipeline development. The initial transaction provides the right to buy the target asset which may provide consistent revenue to the Company while it continues to develop its biotech pipeline drug candidates. The transaction is an assignment and conditional assumption agreement with a seasoned real estate investment group pursuant to which the Company has gained the rights to purchase a 436 unit, multifamily residential property in Houston, Texas.
  • Closed on a private placement transaction in April 2025 and May 2025 for aggregate gross proceeds of approximately $2.6 million related to the issuance of Series D convertible preferred stock.
  • Regained Nasdaq compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. The Company will be subject to a mandatory panel monitor until March 20, 2026.
  • Continued expansion of our patent estate for istaroxime with the granting of a notice of allowance in acute heart failure by the United States Patent and Trademark Office as well as a patent filing in India. For the preclinical oncology aPKCi inhibitor, a patent was issued for Japan.   

Select First Quarter 2025 Financial Results

For the fiscal quarter ended March 31, 2025, the Company reported an operating loss of $4.1 million compared to an operating loss of $4.4 million in the first quarter of 2024.

Research and development expenses were $2.3 million for the first quarter of 2025, compared to $2.3 million for the first quarter of 2024. Research and development expenses primarily relate to the continued development of istaroxime for the treatment of early cardiogenic shock, including costs related to the SEISMiC C trial during the first quarter of 2025 and costs related to the SEISMiC Extension trial during the first quarter of 2024.

General and administrative expenses for the first quarter of 2025 were $1.8 million, compared to $2.1 million for the first quarter of 2024. The $0.3 million decrease in general and administrative expenses is due to a decrease of $0.2 million in professional fees, primarily related to reduced legal fees and a decrease of $0.1 million in non-cash stock-based compensation expense.

The Company reported a net loss attributable to common stockholders of $5.0 million ($4.63 per basic share) on 1,088,564 weighted-average common shares outstanding for the quarter ended March 31, 2025, compared to net income of $10.2 million ($1,099.37 per basic share) on 9,295 weighted average common shares outstanding for the comparable period in 2024.

As of March 31, 2025, the Company reported cash and cash equivalents of $1.2 million and current liabilities of $6.5 million. We believe that we have sufficient resources available to fund our business operations through May 2025. 

Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which was filed with the Securities and Exchange Commission on May 15, 2025, and includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations.

About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a biotechnology company focused on becoming a revenue-generating company and advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company's risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the Company's ability to maintain compliance with the continued listing requirements of Nasdaq; the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in the Israel and Gaza, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact Information:

Eric Curtis
ecurtis@windtreetx.com


WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets

(in thousands, except share and per share data)
  March 31, 2025  December 31, 2024 
  (Unaudited)     
ASSETS        
Current assets:        
Cash and cash equivalents $1,173  $1,779 
Prepaid expenses and other current assets  421   795 
Total current assets  1,594   2,574 
         
Property and equipment, net  94   111 
Restricted cash  9   9 
Operating lease right-of-use assets  939   1,051 
Intangible assets  24,130   24,130 
Total assets $26,766  $27,875 
         
LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $3,110  $1,879 
Accrued expenses  1,785   1,706 
Operating lease liabilities - current portion  519   508 
ELOC commitment note payable  -   328 
Derivative liability - ELOC commitment note  -   299 
Senior secured notes payable  374   - 
Common stock warrant liability  162   305 
Loans payable  167   333 
Other current liabilities  359   359 
Total current liabilities  6,476   5,717 
         
Operating lease liabilities - non-current portion  519   653 
Other liabilities  3,800   3,800 
Deferred tax liabilities  4,643   4,528 
Total liabilities  15,438   14,698 
         
Mezzanine equity:        
Series C redeemable preferred stock, $0.001 par value; 18,820 shares authorized; 2,833 and 11,757 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively  1,038   3,181 
Series B redeemable preferred stock, $0.001 par value; 5,500 shares authorized; 0 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively  -   - 
Total mezzanine equity  1,038   3,181 
         
Stockholders’ equity:        
Preferred stock, $0.001 par value; 4,975,680 shares authorized; 0 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively  -   - 
Common stock, $0.001 par value; 120,000,000 shares authorized; 3,555,954 and 256,397 shares issued and 3,555,953 and 256,396 shares outstanding at March 31, 2025 and December 31, 2024, respectively  4   - 
Additional paid-in capital  863,995   859,660 
Accumulated deficit  (850,655)  (846,610)
Treasury stock (at cost); 1 share  (3,054)  (3,054)
Total stockholders’ equity  10,290   9,996 
Total liabilities, mezzanine equity & stockholders’ equity $26,766  $27,875 


WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations

(in thousands, except share and per share data)
  Three Months Ended 
  March 31, 
  2025  2024 
         
Expenses:        
Research and development $2,270  $2,253 
General and administrative  1,820   2,152 
Total operating expenses  4,090   4,405 
Operating loss  (4,090)  (4,405)
         
Other income (expense):        
(Loss) gain on debt extinguishment, net  (22)  14,520 
Change in fair value of common stock warrant liability  134   - 
Interest income  7   30 
Interest expense  (20)  (13)
Other (expense) income, net  (54)  201 
Total other income, net  45   14,738 
         
(Loss) income before income taxes  (4,045)  10,333 
Income tax expense  -   (114)
Net (loss) income $(4,045) $10,219 
Dividends on Series C preferred stock  (998)  - 
Net (loss) income attributable to common stockholders $(5,043) $10,219 
         
Net (loss) income per share attributable to common stockholders        
Basic and diluted $(4.63) $1,099.37 
         
Weighted average number of common shares outstanding        
Basic and diluted  1,088,564   9,295 

FAQ

What is WINT's current financial position in Q1 2025?

Windtree reported $1.2M in cash and cash equivalents with $6.5M in current liabilities, and an operating loss of $4.1M. The company has funding through May 2025.

How much did Windtree Therapeutics raise in their 2025 private placement?

Windtree raised approximately $2.6 million through a private placement of Series D convertible preferred stock in April and May 2025.

What are the key elements of Windtree's new revenue generation strategy?

The strategy includes acquiring FDA-approved assets, rights to purchase a 436-unit residential property in Houston, PHEXXI manufacturing partnership, and a China partnership expected to generate revenue by end of 2026.

What is the status of WINT's Nasdaq listing compliance?

Windtree regained Nasdaq compliance with the minimum bid price requirement but remains under mandatory panel monitor until March 20, 2026.

What progress has Windtree made with istaroxime development?

Windtree continues enrolling subjects in the istaroxime cardiogenic shock SCAI Stage C study, with an interim analysis of the first 20 subjects planned for Q3 2025.
Windtree Therapeutics Inc

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Biotechnology
Biological Products, (no Disgnostic Substances)
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WARRINGTON